Background: Early rehabilitation programs (ERP) that include physical, occupational, and speech therapies lessen debilitation and promote return to previous physical and cognitive functioning and have been successfully applied in adult intensive care units (ICUs). Despite the fact that critically ill children with acute brain injury (ABI) are at increased risk of life-long disability and stunted development, the benefits of ERP for this group have not been studied and ERPs are not the standard of care in pediatric ICUs (PICUs).
Objectives: The aims of this study are (1) to better understand current practices and barriers to use of these therapies, and (2) to subsequently evaluate ERP vs. usual care in children with ABI in the ICU by randomizing children to these groups and measuring outcomes. The study team expects that ERP therapies are underutilized in PICUs and that outcomes in the ERP group will be superior compared to the usual care group.
Methods: The first task of this research program is to survey healthcare professionals (physicians, nurses, allied health) and families of children in ICUs about their hospital’s resources, current practices, and barriers to ERP. This survey will be distributed to the 78 sites affiliated with the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI), a group of clinicians and researchers dedicated to improving child outcomes from critical illness. Next, we will enroll 175 children with ABI in a randomized controlled trial of ERP versus usual care. Children enrolled in ERP will begin therapies within 48 hours of ICU admission; those in the usual care group will begin therapies when these services are ordered by treating physicians. Children ages 3–17 years with ABI expected to be admitted to the ICU > 48 hours due to trauma, infection, low oxygen, or low blood flow to the brain are eligible. Therapy interventions are individualized for the child’s clinical status. The effectiveness of ERP will be measured using the Vineland Behavior Adaptive Scale (VABS) pre ABI and six months post ABI. This test, validated for children, assesses a child’s physical and cognitive function as well as behavior. Other tests will be performed that assesses child and family quality of life and length of hospital admission. Our outcome tests were chosen because (1) they are the most important outcomes to families of children as surveyed in our ICU, and (2) they are outcomes that can be influenced by ERP.
Summary: This is the first and largest study designed to evaluate whether ERP improves outcomes for critically ill children with ABI. We anticipate that we will find that ICUs lack standard protocols for rehabilitation practices and that the practices are underutilized. We expect that patients in the ERP group will have superior adaptive and quality of life outcomes—outcomes important to families—without increasing adverse events compared with patients in the usual care group.